Process Engineer (Fill-Finish)

Main Responsibilities (SME – fill-finish related projects):
- Assist and develop technically sound process equipment concepts and scope
- Specify and design process equipment
- Manage equipment vendors to meet requirements, cost, and schedule
- Develop and execute commissioning and qualification (CQ) documentation
- Involve Maintenance, Operations, Engineering, Quality, and Continuous Improvement during design
- Ensure knowledge transfer at project close for appropriate support of process equipment

Routine Tasks (Process Equipment Area):
- Train and support development
- Interface with Operations to ensure equipment meets production requirements
- Provide input to quality and safety systems
- Provide advanced technical support to diagnose and resolve complex system issues, minimizing downtime
- Identify and implement improvements to enhance efficiency, safety, and quality

KPIs/Metrics:
- Compliance (deviations, CAPA, change control, training)
- Work order metrics; CQ completion rate
- Deviations and discards due to equipment issues

Qualifications:
- BS in Engineering (Chemical or Mechanical preferred) or related field
- 5+ years in aseptic processing, sterile manufacturing, or fill-finish engineering; hands-on experience with filling equipment and aseptic barriers

Required/Preferred Skills:
- Technical knowledge of drug product processes; automated mechanical systems
- GMP knowledge for manufacturing and CQ activities; analytical and troubleshooting skills
- Experience with lyophilization, CIP/SIP systems, filling technologies; sterile manufacturing
- Ability to lead small projects; understanding of utilities impact
- Cost/schedule/scope management; automation design/testing knowledge; proficient in written/spoken English

Benefits (if offered): healthcare/wellbeing programs and at least 14 weeks’ gender-neutral parental leave.